Safety Study of GRNOPC1 in Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).

The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.

Secondary Outcome Measures
:

Neurological function [ Time Frame: One year ]

The secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.